Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel
LRTI
1 other identifier
observational
1,689
1 country
8
Brief Summary
This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively collect and test residual Bronchoalveolar lavage (BAL) and sputum specimens and generate performance data to support regulatory classification of the FilmArray LRTI as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 29, 2017
CompletedFirst Posted
Study publicly available on registry
December 5, 2017
CompletedDecember 5, 2017
November 1, 2017
9 months
November 29, 2017
November 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
sensitivity and specificity of device
10 months
Study Arms (1)
Specimens that meet inclusion criteria
Interventions
Eligibility Criteria
Only residual BAL or sputum specimens from patients with clinician-ordered lower respiratory pathogen testing will be enrolled.
You may qualify if:
- Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted under clinician order for standard care LRT testing
- Specimen has not been centrifuged
- Specimen has not been pre-treated
- Specimen has at least 1.5 mL of residual volume
- Specimen was collected from a subject not already enrolled in the study
- Specimen is fresh (stored at \~4°C, not frozen) and was enrolled with 24 hours of collection
You may not qualify if:
- Specimen was centrifuged, pre-treated, or is less than 1.5mL
- Specimen was collected from a subject known to have cystic fibrosis
- Specimen was collected from a subject known to have tuberculosis
- Specimen was collected from a subject that was previously enrolled in the study
- Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California, Los Angeles
Los Angeles, California, 90095, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Ohio State University College of Medicine
Columbus, Ohio, 43210, United States
Wisconsin Medical Center
Milwaukee, Wisconsin, 53226, United States
Biospecimen
Bronchoalveolar lavage (BAL) or sputum
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2017
First Posted
December 5, 2017
Study Start
October 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
December 5, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share